Nemaura Medical Inc (NASDAQ:NMRD) CEO Faz Chowdhury told investors Thursday that the company has “successfully completed” the clinical studies needed to support a De Novo submission to the US Food & Drug Administration (FDA) for approval of sugarBEAT, the world’s first painless non-invasive glucose monitor.
Chowdhury told investors that the company plans to apply to the FDA in the second quarter of 2019, which could speed up sugarBEAT’s arrival on American shores.
For certain low-risk novel devices, the FDA's De Novo pathway offers a swifter route to market.
The FDA created the De Novo process in 1997 as an alternative pathway for companies bringing novel Class I and Class II devices to market via the pathway. The goal is to bring more transparency and predictability for manufacturers.
SugarBEAT is targeted at people with Type I and Type II diabetes, as well as for screening prediabetic patients.
De Novo submission to FDA
“We are currently preparing our dossier for FDA submission,” Chowdhury told investors in a letter to shareholders.
He added that clinical studies to support the upcoming FDA De Novo submission was split between Type I and Type II diabetics and consisted of 75 patients who were monitored over 225 days. The studies generated over 12,000 paired data points, with blood samples taken via a catheter every 15 minutes over a 12-hour period for three non-consecutive days for each patient.
The study design was based on two previous meetings Nemaura held with the FDA, ensuring the study was sufficiently powered to provide statistically valid results. Overall the clinical study results indicated a mean absolute relative difference (MARD) of 11.92% (with a lower figure denoting greater accuracy) for 95.95% of the paired data points, using a single point finger prick calibration. There was no device-related adverse event.
Progress towards CE Mark
SugarBEAT, which has been honed and perfected over seven years is expected to receive CE approval in the UK soon. It will launch first in the UK and then the rest of Europe and Qatar.
“We continue to make significant progress towards completion of our CE Mark,” said Chowdhury. “The clinical review was completed in December 2018, and based on the ongoing dialogue, we are now in the final stages of the review process, after which Nemaura expects CE approval will be issued.”
The company said it had made further enhancements to sugarBEAT with a sign-off from the British Standards Institute.
A predecessor sugarBEAT device from Nemaura, which was based on a wired wrist-watch form factor, received CE Mark approval in 2016.
“The outlook for the business is extremely encouraging and we are confident in our ability to secure regulatory approval,” said Chowdhury.
The global addressable market for continuous glucose monitoring devices is estimated at $82 billion annually, and over $13 billion in the US alone.
According to the Centers for Disease Control and Prevention, more than 100 million Americans have diabetes or prediabetes, the precursor to diabetes marked by higher than normal blood sugar levels.
Since sugarBEAT doesn’t require needles or insertion, it is likely to disrupt the continuous glucose monitor (CGM) device market. It will challenge entrenched players like DexCom Inc (NASDAQ:DXCM), which markets the Dexcom G6 and Abbott Laboratories (NYSE:ABT) Libre System.
SugarBEAT consists of a daily disposable adhesive skin-patch connected to a rechargeable transmitter, with an app displaying glucose readings at five-minute intervals for periods up to 24 hours. The innovation of sugarBEAT lies in its groundbreaking skin-patch technology, which allows for better glucose management.
“Our product includes significant and unique features that the competition does not provide, in particular the non-invasive nature of the device and the flexible wear period,” said Chowdhury. “We believe these advantages will allow SugarBEAT to become adopted by a very large and diverse patient and user group.”
Chowdhury, a serial inventor and entrepreneur, is the brains behind sugarBEAT. The pharmaceutical scientist received his PhD in Nanomedicine from the University of Oxford. Today, Chowdhury holds 50 patents on drug delivery systems and sensors, across 15 technology platforms.
Contact Uttara Choudhury at [email protected]